Telephone-Based Program to Promote Inhaled Corticosteroid Adherence Among Individuals With Asthma

Asthma Clinical Trial

Official title:

Phone Calls to Promote Adherence With Inhaled Corticosteroids

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00414817
• Other study ID #: 443
• Secondary ID: R01HL083433-01A1
• Status: Active, not recruiting
• Phase: N/A
• First received: December 20, 2006
• Last updated: June 3, 2010
• Start date: June 2007
• Est. completion date: June 2011

Study information

• Verified date: April 2009
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Inhaled corticosteroids (ICS) are often prescribed as a treatment for asthma. However, many individuals who take these medications do not adhere to their prescribed treatment regimen. The purpose of this study is to evaluate the effectiveness of a telephone-based program at improving medication adherence among individuals with asthma.

Description:

Asthma is a serious, chronic disease that affects lung function and impairs an individual's ability to breathe normally. ICS reduce airway inflammation and are often prescribed to treat these conditions. However, poor medication adherence is a common problem that can lead to treatment failure, hospitalization, or death. A telephone-based system that uses interactive voice recognition technology to remind individuals to follow their medication regimen may prove beneficial in promoting adherence. The purpose of this study is to evaluate the effectiveness of such a telephone-based intervention at improving adherence to inhaled corticosteroid regimens among individuals with asthma. If this study proves successful, telephone-based interventions may be developed to promote treatment adherence for other chronic medical conditions.

This 19-month study will enroll approximately 14,000 members of the Kaiser Permanente Northwest or Hawaii health system. Participants will be randomly assigned to either take part in the telephone intervention or receive usual medical care. Over the 19-month period, participants in the intervention group will receive between one and eight phone calls that will remind them to refill their prescriptions and offer education about ICS. If needed, the call may also offer a transfer to a pharmacy refill line or to speak with a pharmacist. Approximately 2,000 participants will complete questionnaires at study entry and at the end of the 19-month intervention period. The questionnaires will assess quality of life, respiratory health, asthma control, depression, inhaler use beliefs, and satisfaction with the intervention. Electronic medical record data and questionnaires will be used to determine adherence rates.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14064
• Est. completion date: June 2011
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Received treatment for asthma in the year prior to study entry

• Received at least one respiratory medication at a Kaiser Permanente Northwest (KPNW) or Kaiser Permanente Hawaii (KPH) outpatient pharmacy in the year prior to study entry

• Continuous Kaiser Permanente membership from the year prior to study entry through study entry

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Telephone-Based Medication Adherence Intervention
The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions.

Locations

Country	Name	City	State
United States	Center for Health Research/KPH	Honolulu	Hawaii
United States	Center for Health Research-KPNW	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days supply of inhaled corticosteroids available as documented in patients' pharmacy records will measure adherence to inhaled corticosteroids		Measured at 19 months	No
Secondary	Survey responses from a subset of our population and medical record data will be used to measure participant health status		Measured at 19 months	No
Secondary	Medical record data will be used to measure rate of acute health care utilization for asthma		Measured at 19 months	No
Secondary	An economic analysis will be conducted using medical record data to assess cost of acute health care utilization for asthma		Measured at 19 months	No